How does the role the Quality Assurance (QA) Auditor differ within the EASA environment compared to say other aviation regulatory systems? (FAA for example?)
Well, the first thing to consider is that the role of the Quality Assurance Auditor within the EASA system is quite specific in that it requires “Independence” This is not the case for example when you consider ISO 9001-2015.
9001: 2015 has removed the requirement for a single point of contact regarding the QMS replacing it with a new section on leadership to better emphasis a greater involvement from the leadership team. Compare with EASA where we have specific roles and responsibilities (Including Independent Compliance Manager (CM) and a clear understanding of who is managing each business objective, whilst still ultimately identifying the responsibility of the nominated persons.
The second aspect to consider is that the primary objective of the EASA system is to demonstrate compliance (with little focus on other quality related aspects or elements for example the “performance of the system”) When we speak about Organisational Compliance we are talking about compliance with all external regulatory requirements together with all the internal obligations driven by all internal company documentation, manuals and procedures.
The CM heads up the independent process for performing a gap analysis (auditing for conformity) of the organisations documentation systems and processes.
Any finding becomes a “discrepancy” and generates the need for “corrective action”.
Within the EASA system the following is applicable:
Consider the following role definitions and responsibilities:
a) The Accountable Manager is responsible for the Quality System which includes both elements of Quality Control and Quality Assurance;
b) The Quality Assurance Manager [Compliance Manager (CM)] is responsible for the auditing of all Compliance related elements of the organisation system;
c) “Quality Audit” is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team;
d) Whenever we perform a quality audit, there will always be a reference or “standard” against which the audit is carried out. So another way of thinking about the audit is to consider it is a comparison against the standard or a “Gap Analysis”;
e) The responsibility of the quality assurance auditor is to periodically test and assess quality control systems. Quality Control related to the physical act of production within the organisation;
f) Quality Control is typically the responsibility of the individual post holders and business area owners. Quality Control is delivered through the development of regulatory compliant organisational processes and procedures which are followed by suitably trained and competent organisational staff;
g) Independently all QC processes should be audited by the QA process;
h) Consider also that there is an organisational need for the Quality System to Audit the SMS System.
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Tags:
Aviation Quality, EASA, European Aviation Safety Agency, Aviation Quality Assurance Auditor
